A New Antibiotic Prophylaxis Regimen to Prevent Bacteremia Following Dental Procedures

May 26, 2015 updated by: Pedro DIz DIos, University of Santiago de Compostela

The aim of this study is to evaluate the efficacy of prophylactic dosage with amoxicillin (AMX), amoxicillin-clavulanate (AMX-CLV), and a combination of amoxicillin-clavulanate and a chlorhexidine mouthwash (AMX-CLV-CHX) in the prevention of bacteremia following dental extractions.

The study hypothesis is that an antimicrobial regimen with amoxicillin-clavulanate will show higher effectiveness in reducing the prevalence and duration of bacteremia following dental extractions, than that achieved with the classical amoxicillin regimen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PURPOSE: Despite the controversy about the risk of developing bacterial endocarditis of oral origin, numerous Expert Committees in different countries continue to publish prophylactic regimens. To date, the literature is unclear about the role of antimicrobial prophylaxis in the prevention of bacteremia following dental procedures. The aim of this study is to evaluate the efficacy of prophylactic dosage with amoxicillin (AMX), amoxicillin-clavulanate (AMX-CLV), and a combination of amoxicillin-clavulanate and a CHX mouthwash (AMX-CLV-CHX) in the prevention of bacteremia following dental extractions.

SELECTION OF THE STUDY GROUP AND STUDY DESIGN: The study group will comprise patients who, for behavioral reasons (autism, learning disabilities, phobias, etc.), will undergo dental extractions under general anesthesia in the Santiago de Compostela University Hospital (Santiago de Compostela, Spain). The following exclusion criteria will be applied: age under 18 years; body weight under 40 kg; receipt of antibiotics in the previous 3 months; routine use of oral antiseptics; a history of allergy or intolerance to AMX, CHX or AMX-CLV; any type of congenital or acquired immunodeficiency; or any known risk factor for bacterial endocarditis. By applying these criteria, 200 patients will be selected and will be randomly distributed into 5 study groups: control group (receiving no prophylaxis), AMX group (receiving 2 g AMX i.v.), AMX-CLV group (receiving 1000/200mg AMX-CLV i.v.), CHX group (receiving a single 0.2% CHX mouthwash for 30 seconds), and AMX-CLV-CHX group (receiving 1000/200mg AMX-CLV i.v. and a single 0.2% CHX mouthwash for 30 seconds).

COLLECTION OF SAMPLES FOR BLOOD CULTURE: To determine the prevalence of bacteremia, a peripheral venous blood sample (10 ml) will be drawn from each patient at the baseline (before any dental manipulation but after nasotracheal intubation) and 30 s, 15 min, and 1 h after the final dental extraction. Samples will be inoculated in BACTEC plus (Becton Dickinson and Company, Sparks, MD) aerobic and anaerobic blood culture bottles, and will be processed in the Bactec 9240 (Becton Dickinson).

MICROBIOLOGICAL ANALYSIS OF BLOOD CULTURES: A Gram stain will be performed on each positive blood culture. The positive blood cultures in the aerobic media will be subcultured on blood agar and chocolate agar in an atmosphere of 5 to 10% carbon monoxide and on MacConkey agar under aerobic conditions. The same protocol will be used for the positive blood cultures in the anaerobic media, with subculture on Schaedler agar and incubation in an anaerobic atmosphere. The bacteria isolated will be identified by using the battery of biochemical tests provided with the Vitek system for Gram-positive bacteria, Neisseria spp., Haemophilus spp., and obligate anaerobic bacteria. The viridans group streptococci will be classified into five groups, the Streptococcus mitis, S. anginosus, S. salivarius, S. mutans, and S. bovis groups, by applying the Ruoff criteria. Facklam's criteria will be used to identify unusual Streptococcus spp. and other gram-positive cocci in chains.

The subculture and further identification of the isolated bacteria will be performed by conventional microbiological techniques. The collection, handling, and transport of the blood samples for blood culture will be performed according to the recommendations of the Spanish Society of Infectious Diseases and Clinical Microbiology.

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Study Type

Interventional

Enrollment (Actual)

266

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15782
        • Hospital Clinico Universitario de Santiago
    • Coruña
      • Santiago de Compostela, Coruña, Spain, 15782
        • Santiago de Compostela University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must have at least 10 teeth
  • Subjects must have the need for a dental extraction under general anesthesia (for behavioral reasons)
  • Subjects will be recruited regardless of the extent and severity of their dental and/or periodontal disease

Exclusion Criteria:

  • Age under 18 years
  • Body weight under 40 kg
  • Receipt of antibiotics in the previous 3 months
  • Routine use of oral antiseptics
  • A history of allergy or intolerance to amoxicillin
  • A history of allergy or intolerance to chlorhexidine
  • A history of allergy or intolerance to amoxicillin-clavulanate
  • Any type of congenital or acquired immunodeficiency
  • Any known risk factor for bacterial endocarditis
  • Any known risk factor for prolonged bleeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Receiving no prophylaxis
Active Comparator: Amoxicillin
Receiving 2 g Amoxicillin intravenously before any dental manipulation and following endotracheal intubation
Drug: Amoxicillin
Administer Amoxicillin following endotracheal intubation prior to single tooth-extraction
Other Names:
  • AMOXICILINA SANDOZ EFG (code 694688)
Experimental: Amoxicillin-Potassium Clavulanate
Receiving 1000/200mg Amoxicillin-Potassium Clavulanate i.v. before any dental manipulation and following endotracheal intubation
Drug: Amoxicillin-Potassium Clavulanate
Administer Amoxicillin-Potassium Clavulanate following endotracheal intubation prior to single tooth-extraction
Other Names:
  • AMOXICILINA + ACIDO CLAVULANICO SANDOZ EFG (code 600144)
Active Comparator: Chlorhexidine (CHX)
Receiving a single 0.2% Chlorhexidine (CHX) mouthwash for 30 seconds before any dental manipulation and following endotracheal intubation
Drug: Chlorhexidine
Administer Chlorhexidine Digluconate following endotracheal intubation prior to single tooth extraction
Other Names:
  • Oraldine Perio (code 375725)
Experimental: Amoxicillin-Potassium Clavulanate-CHX
Receiving 1000/200mg Amoxicillin-Potassium Clavulanate i.v. and a single 0.2% Chlorhexidine (CHX) mouthwash for 30 seconds before any dental manipulation and following endotracheal intubation
Drug: Amoxicillin-Potassium Clavulanate
Administer Amoxicillin-Potassium Clavulanate following endotracheal intubation prior to single tooth-extraction
Other Names:
  • AMOXICILINA + ACIDO CLAVULANICO SANDOZ EFG (code 600144)
Drug: Chlorhexidine
Administer Chlorhexidine Digluconate following endotracheal intubation prior to single tooth extraction
Other Names:
  • Oraldine Perio (code 375725)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants receiving a prophylactic dosage with amoxicillin-clavulanate i.v. with bacteremia following dental extractions
Time Frame: Changes from baseline in prevalence of bacteremia at 30 seconds, 15 minutes and 1 hour after the final dental extraction
Percentage of participants receiving a prophylactic dosage with amoxicillin-clavulanate i.v. with bacteremia confirmed by microbiological analysis at 30 seconds, 15 minutes and 1 hour after the final dental extraction
Changes from baseline in prevalence of bacteremia at 30 seconds, 15 minutes and 1 hour after the final dental extraction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants receiving a prophylactic dosage with amoxicillin i.v. (following the American Heart Association´s guidelines) with bacteremia after dental extractions
Time Frame: Changes from baseline in prevalence of bacteremia at 30 seconds, 15 minutes and 1 hour after the final dental extraction
Percentage of participants receiving a prophylactic dosage with amoxicillin i.v. with bacteremia confirmed by microbiological analysis at 30 seconds, 15 minutes and 1 hour after the final dental extraction
Changes from baseline in prevalence of bacteremia at 30 seconds, 15 minutes and 1 hour after the final dental extraction

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of control participants with bacteremia following dental extractions under general anesthesia
Time Frame: Changes from baseline in prevalence of bacteremia at 30 seconds, 15 minutes and 1 hour after the final dental extraction
Percentage of control participants with bacteremia confirmed by microbiological analysis at 30 seconds, 15 minutes and 1 hour after the final dental extraction
Changes from baseline in prevalence of bacteremia at 30 seconds, 15 minutes and 1 hour after the final dental extraction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Santiago de Compostela

Collaborators

Hospital Clinico Universitario de Santiago

Investigators

  • Study Chair: Pedro Diz, MD,DDS,PhD, Universidad de Santiago (Grupo OMEQUI-2117); Hospital Clínico Universitario de Santiago
  • Study Director: Jacobo Limeres, DDS,PhD, Universidad de Santiago (Grupo OMEQUI-2117)
  • Principal Investigator: Javier Alvarez, MD,DDS, Universidad de Santiago (Grupo OMEQUI-2117)
  • Principal Investigator: Javier F Feijoo, MD,DDS,PhD, Universidad de Santiago (Grupo OMEQUI-2117); Hospital Clínico Universitario de Santiago
  • Principal Investigator: Marcio Diniz, DDS,PhD, Universidad de Santiago (Grupo OMEQUI-2117)
  • Principal Investigator: Mercedes Outumuro, DDS,PhD, Universidad de Santiago (Grupo OMEQUI-2117)
  • Principal Investigator: Juan Medina, MD,Anest,PhD, Hospital Clinico Universitario de Santiago
  • Principal Investigator: Miguel Castro, MD,DDS, PhD, Universidad de Santiago (Grupo OMEQUI-2117)
  • Principal Investigator: Maximiliano Alvarez, MD,Micro,PhD, Hospital Clinico Universitario de Vigo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

April 8, 2014

First Submitted That Met QC Criteria

April 14, 2014

First Posted (Estimate)

April 16, 2014

Study Record Updates

Last Update Posted (Estimate)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PGIDIT05PXIB92501PR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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